Abstract 526P
Background
No standard treatment strategy for patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC) experiencing progression after one or more lines of chemotherapy. The aim of this study was to assess the efficacy and safety of apatinib, an oral vascular endothelial growth factor receptor 2 (VEGFR-2) tyrosine kinase inhibitor, in patients with recurrent/metastatic ESCC for whom at least one line of prior chemotherapy had failed.
Methods
This was a phase II trial that enrolled patients with recurrent/metastatic ESCC who had evidence of disease progression after first-line or more lines chemotherapy. All patients received continuous apatinib 500mg once daily until disease progression, death, or intolerable toxicity, dose escalation was allowed. The primary end point was progression free survival (PFS).
Results
Between July 2017 and August 2018, 40 patients were recruited. Data was cutoff at June 26, 2019. Among the 40 patients, 5 patients achieved partial response while 21 had stable disease. Primary end point median PFS (mPFS) was 113 days (95% 45-180). Median OS (mOS) was 158 days (95% 101-215), Objective response rate (ORR) was 12.5%. The incidence of drug-related adverse events (AEs) was 87.5%. 40.0% patients developed severe AEs. Main AEs were Fatigue (37.5%), Hand-foot syndrome (27.5%) and Hypertension (25%). Two patients with massive hemoptysis, and two patients with tracheal esophageal fistula had the uncontrolled primary tumor or trachea/bronchi eroded.
Conclusions
The study confirmed that apatinib was effective as second-line or more lines treatment for recurrent/metastatic ESCC patients, and most adverse effect were acceptable. However, patients with uncontrolled primary tumor or trachea/bronchi eroded should been cautiously considered to use.
Clinical trial identification
NCT03274011.
Editorial acknowledgement
Legal entity responsible for the study
Fudan University Shanghai Cancer Center.
Funding
Jiangsu Hengrui Medicine.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
117P - Short-term and long-term outcomes of hepatectomy combined with intraoperative radiofrequency ablation for multiple colorectal liver metastases: A propensity score matching study
Presenter: Wenbai Huang
Session: Poster display session
Resources:
Abstract
119P - The impacts of dose-time-fractionation schedules on pathological complete response rate (pCR) and local recurrence (LR)
Presenter: Fu Jin
Session: Poster display session
Resources:
Abstract
120P - Platelet to lymphocyte ratio is associated with tumour localization and outcomes in patients with metastatic colorectal cancer
Presenter: Ahmet Bilici
Session: Poster display session
Resources:
Abstract
121P - Meta-analysis of three-dimensional versus two-dimensional laparoscopic surgery for rectal cancer
Presenter: Laiyuan Li
Session: Poster display session
Resources:
Abstract
127P - Outcomes based on albumin‐bilirubin (ALBI) grade in the phase III CELESTIAL trial of cabozantinib versus placebo in patients with advanced hepatocellular carcinoma (HCC)
Presenter: Stephen Chan
Session: Poster display session
Resources:
Abstract
128P - Tislelizumab in combination with chemotherapy for Chinese patients (Pts) with gastric/gastroesophageal junction cancer (GC/GEJC) or esophageal squamous cell carcinoma (ESCC)
Presenter: Yuxian Bai
Session: Poster display session
Resources:
Abstract
129P - Monitoring patient-specific mutation in ctDNA and CTC for tumour response evaluation after neoadjuvant chemotherapy in advanced gastric adenocarcinoma (NCT03425058)
Presenter: Tao Fu
Session: Poster display session
Resources:
Abstract
130P - Development of a liver cancer risk prediction model for the general population in china: A potential tool for screening
Presenter: Xiaoshuang Feng
Session: Poster display session
Resources:
Abstract
131P - Cabozantinib in Asian patients with hepatocellular carcinoma and other solid tumours: Population pharmacokinetics analysis
Presenter: Chih-Hung Hsu
Session: Poster display session
Resources:
Abstract
132P - Liposomal irinotecan (nal-IRI) plus 5-fluorouracil/levoleucovorin (5 FU/LV) vs 5-FU/LV in Japanese patients (pts) with gemcitabine-refractory metastatic pancreatic cancer (mPAC)
Presenter: Tatsuya Ioka
Session: Poster display session
Resources:
Abstract